# K143307: RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector

- Pathway: 510(k) (Special)
- Applicant: Rayner Intraocular Lenses, Ltd.
- Decided: Dec 18, 2014 after 30 days
- Product code: MSS (Folders And Injectors, Intraocular Lens (Iol))
- Device class: 1
- Regulation: 21 CFR 886.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K914311 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132002: Single Use Soft Tipped Disposable Injector, Raysert Single Use Soft Tipped Small Incision Disposable Injector, Rayner Intraocular Lenses, Ltd. (2014) Summary page 5.

## Indications for use
The Rayner Injectors (Models STWO01 and RSP01) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labeling.

Source page: https://510kreport.com/device/K143307
Methodology: https://510kreport.com/methodology